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Completed

NCT Number: NCT05525390

Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major MDD Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

About this study

This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must meet DSM V criteria for MDD
  • Patient must be at least 18 years of age
  • Patient must be English speaking

Exclusion criteria

  • Substance Use Disorders in past year
  • Any psychosis or bipolar disorder
  • Any seizure in the last 6 months or untreated epilepsy
  • Current nonsuicidal self-injury or parasuicidal behavior
  • Current suicidal urges and intent
  • Changing psychotherapy treatment within four months of study entry
  • Changing psychotropic medication(s) within two months of study entry

Treatment and study plan

Extended Reality-Enhanced Behavioral Activation

Behavioral

Participants will choose at least four "activities" to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.

Traditional Behavioral Activation

Behavioral

Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.

Primary outcomes

  1. Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms

    Time frame: Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).

    How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. The PHQ-9 is a 9-question screener with a score range of 0-29, with 29 indicating the most severe depression and 0 indicating a lack of depression symptoms. The greater the change over time, the greater the symptom reduction.

Secondary outcomes

  1. Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends

    Time frame: Assessed after session 4, at the end of week 3.

    This outcome was measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 3 questions, the total range was 0-12 (higher scores indicate greater acceptance).

  2. Number of Participants Who Dropped Out of Each Study Arm

    Time frame: 3-weeks

    Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.

  3. Participant's Satisfaction With the XR-Enhanced BA Treatment

    Time frame: Assessed after session 4, at the end of week 3.

    This outcome was measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 4 questions, the total range was 0-16 (higher scores indicate greater acceptance).

  4. Participant's Use of the XR Headset

    Time frame: Assessed after session 4, at the end of week 3.

    This was measured by noting the amount of times the XR headset is used during the 3-week study period.

  5. Participant's Acceptance of XR-Enhanced BA Treatment

    Time frame: Assessed after session 4, at the end of week 3.

    This was measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4), yielding a range of 0-52 (higher scores indicate greater acceptance).

  6. How Well Can Participants Tolerate the XR-Enhanced BA Treatment?

    Time frame: Assessed after session 4, at the end of week 3.

    This was determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual (0), Slightly more than usual (1), Moderately more than usual (2), or Severely more than usual (3), yielding a range of 0-48 (lower scores indicate greater tolerability).

  7. How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?

    Time frame: Assessed after session 4, at the end of week 3.

    This was measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all (0), Slightly (1), Moderately (2), Strongly (3), or Very Strongly (4), yielding a range of 0-12 (higher scores indicate greater presence).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2022
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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